FDA Requests Public Input on Quality Metrics Guidance

Which quality metrics are you tracking  for audits and inspections? The FDA is seeking input  on the types of data that contribute to a culture of quality.   by Oliver Wolf, Senior Product Manager, MasterControl In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points. The guidance expands on how the FDA intends to act on its ability to request data it would normally inspect during an audit “in advance or in lieu of” an inspection, as it is authorized to do under Section 704(a)(4)(A) of the FD&C Act (added by FDASIA section 706, Records for Inspection). It also points out that failure to provide the requested data is tantamount to refusal to permit an inspection and would render the affected product adulterated according to Section 501(j).

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FDA Requests Public Input on Quality Metrics Guidance 2015-08-27T09:32:00-07:00 Rating: 4.5 Diposkan Oleh: Unknown